Apparatus and method for removing intra-osseous device

ABSTRACT

Apparatuses, systems, and methods are provided for securing an intra-osseous device within a safety device to prevent stick injuries and to guide the removal of the intra-osseous device from the bone of a patient. A body of the safety device has a cavity that receives the intra-osseous device, and the cavity guides the removal of the intra-osseous device along a straight line to prevent injury during removal. The intra-osseous device is drawn past a lock feature that secures the intra-osseous device within the body such that a needle of the intra-osseous device is contained within a cavity of the body and cannot injure the patient, staff members, etc.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 16/179,718, filed on Nov. 2, 2018, now U.S. Pat. No.10,959,755, issued on Mar. 30, 2021, which claims the benefit of U.S.Provisional Application No. 62/580,524, filed Nov. 2, 2017, the entiredisclosures of which are hereby incorporated herein by reference.

FIELD

The present disclosure provides an apparatus, system, and method forsafely removing an intra-osseous device from a body into an enclosedcontainment unit.

BACKGROUND

Every year, hundreds of thousands of sharps related injuries occur amonghealthcare workers. For example, according to the Center for DiseaseControl and Prevention (CDC) over 385,000 sharps related injuries occurannually. Aside from the stress and risk of blood borne pathogensassociated with sharps injuries (Hepatitis B, Hepatitis C, HumanImmunodeficiency Virus, syphilis, malaria, herpes, etc.), there arehealthcare costs: loss of time, testing and treatment also increasecosts and place the burden on healthcare workers, employers, andsociety.

Sharps safety is such a serious issue that the United States Congresspassed the Needlestick Safety and Prevention Act and guides regulatoryagencies like the Occupational Safety & Health Administration (OSHA)with regard to blood borne pathogen standards and mandatesimplementation of safer medical devices.

According to the National Institute of Occupational Safety and Health(NIOSH), the design of the device can increase the risk of injury.Specific features make certain devices more dangerous. These include:(NIOSH, 1999) devices with hollow-bore needles, needle devices that needto be taken apart or manipulated by the health care worker such asblood-drawing devices that need to be detached after use, syringes thatretain an exposed needle after use, and needles that can be difficult toplace in sharps containers.

Safety devices such as needleless or protected-needle systems, needleshielding, and encased needles have been effective at reducingaccidental sharp exposures. However, there is a paucity of safetydevices for medical apparatuses that gain access to bone marrow.Currently, medical devices that gain access to bone marrow, especiallythose that insert a penetrator or needle, contain all the specificfeatures of a medical device at high risk for iatrogenic injuries.

Commonly known as intra-osseous devices, these devices present uniquecharacteristics from other medical devices associated with sharpsinjuries. Since intra-osseous devices must enter cortical bone, theytend to be extremely sharp and typically have more than a single cuttingsurface or point to increase cortical bone penetration. Intra-osseousdevices are typically of a larger caliber than commonly used needles andperipheral vascular access devices. Intra-osseous devices carry greaterrisk of bodily contamination due to microscopic fractured bone fragmentsin addition to blood component exposure.

The technique of removal of an intra-osseous medical device is a crucialstep for patient and healthcare worker safety. Due to the bone matrixand micro-fractures associated with placement of the medical devices,withdrawal of these devices must occur in the opposite vector of theplacement to minimize worsening of the fracture area. Angulation of thedevice during withdrawal is associated with increased chance ofworsening micro-fractures of the bone and increased risk of devicefailure and lodgment in the subject bone.

The technique of removal can be complicated by initial incorrectplacement of an intra-osseous device. Placement in dense cortical bonemay necessitate significant force to overcome the initial resistance ofthe cortical bone. However, once initial resistance is overcome, theforce exponentially decreases over a very short interval. The rapiddecline in resistance creates another dangerous opportunity for sharpsinjury; healthcare workers have been known to physically jerk upon thedevice's release from the bone and potentially impale the worker orassistants during device removal.

SUMMARY

In accordance with the present disclosure, an apparatus, system, andmethod for consistent and safe removal of an intra-osseous device intoan enclosed locking unit are provided. In some embodiments, a safetydevice is configured to guide the removal of the intra-osseous devicefrom a patient's body along a straight line and/or along the line thatthe intra-osseous device was inserted into the patient's body. As aresult, the intra-osseous device does not damage bone or tissue as theintra-osseous device is removed.

In addition, as the intra-osseous device is removed, the safety devicesafely houses the intra-osseous device to prevent sharps relatedinjuries to the patient, staff, etc. The intra-osseous device cangenerally have an aperture through which the intra-osseous device isdrawn. The intra-osseous device passes a lock feature on the innersurface of the safety device, and the intra-osseous device is securedbetween the lock feature and a second end or aperture of the safetydevice. Once secured, the needle or other similar feature of theintra-osseous device is contained within the safety device to preventsharps related injuries.

In accordance with one embodiment of the present disclosure, the body ofthe safety device has a frustum shape. The apex of the frustum has acentral aperture with a diameter large enough to accommodate an average12 mL or smaller syringe. The overall height of the frustum is greaterthan the length of the intra-osseous device. This allows theintra-osseous device to be completely enclosed in the safety devicewithout the intra-osseous device's trochar or needle protruding outsideof the containment of the safety device. Typically the overall height is1.1-1.2 times the overall length of the intra-osseous device to beremoved. An internal spatial volume within said frustum is sufficientfor containing and securing the entirety of the intra-osseous device.The base of the frustum has a central aperture with a diameter that isbetween 1.1-1.2 times the maximum outer diameter of the intra-osseousdevice. The outer body of the frustum is solid to contain potentialbiologic material. The cavity within the safety device is cylindrical tomaintain the correct vector for intra-osseous device removal. The deviceretaining and locking mechanism operates as a single unit. There are nointricate parts, no difficult manipulations, and no cumbersome featuresor structures to control. The safety device is structurally simple andeasy to operate.

In accordance with another embodiment of the present disclosure, thebody of the safety device has a frustum shape. The apex of the frustumhas a central aperture in a diameter large enough to accommodate anaverage 12 mL or smaller syringe. The overall height of the frustum isgreater than the length of the intra-osseous device. This allows theintra-osseous device to be completely enclosed in the device without theintra-osseous device's trochar or needle protruding outside of thecontainment of the apparatus. Typically, the overall height is 1.1-1.2times the overall length of the intra-osseous device to be removed. Aninternal spatial volume within said frustum is sufficient for containingand securing the entirety of the intra-osseous device. The base of thefrustum has a central aperture in a diameter 1.1-1.2 times the maximumouter diameter of the intra-osseous device to be removed.

Immediately proximal to the spatial volume required to contain the fullyretracted intra-osseous device, is the integral locking mechanism, aridge of material which constricts the internal circumference of theinner cylinder to a diameter that is smaller than the outer diameter ofthe intra-osseous device. Two narrow median grooves extend from the baseof the frustum to a distance distal to the integral locking device. Thisdistance is propriety to and dependent upon materials in order to allownatural flexing of the safety device to allow passage of theintra-osseous device beyond the locking ring into the fully retractedstate. The cavity of the safety device is shaped as a cylinder. Thisdesign feature maintains the correct vector for intra-osseous deviceremoval. The device retaining and locking mechanism operates as a singleunit. There are no intricate parts, no difficult manipulations, and nocumbersome features or structures to control. The safety device isstructurally simple and easy to operate.

In accordance with a further embodiment of the present disclosure, thebody of the safety device has a cylindrical shape. One end of thecylinder has a central aperture in a diameter large enough toaccommodate an average 12 mL or smaller syringe. The overall height ofthe cylinder is greater than the length of the intra-osseous device.This allows the intra-osseous device to be completely enclosed in thedevice without the intra-osseous device's trochar or needle protrudingoutside of the containment of the apparatus. Typically, the overallheight is 1.1-1.2 times the overall length of the intra-osseous deviceto be removed. An internal spatial volume with said cylinder issufficient for containing and securing the entirety of the intra-osseousdevice.

The other end of the cylinder has a central aperture in a diameter1.1-1.2 times the maximum outer diameter of the intra-osseous device tobe removed. The outer body of the cylinder is solid to contain potentialbiologic material. The cavity of the safety device is shaped as acylinder. This design feature maintains the correct vector forintra-osseous device removal. The device retaining and locking mechanismoperates as a single unit. There are no intricate parts, no difficultmanipulations, and no cumbersome features or structures to control. Thesafety device is structurally simple and easy to operate.

In accordance with an embodiment of the present disclosure, the lockfeature is positioned in the containment cylinder of the frustumimmediately proximal to the fully retracted intra-osseous device. Thelocking mechanism is circumferential to allow several independent pointsof contact preventing disengagement of the intra-osseous device. Thelocking mechanism is a wedge with the widest portion most proximal tothe fully retracted intra-osseous device. The narrowest portion of thewedge functions as the pivot point of the locking mechanism,facilitating movement of the locking mechanism out of the internalcylinder as the intra-osseous device is retracted fully into thecontainment cylinder. The wedge moves back into the lumen of thecylinder due to the structural integrity of the material the lockingmechanism is composed of. With accordant with another embodiment of thepresent disclosure, the lock feature pushes the locking wedge back intothe lumen of the containment cylinder.

One particular embodiment of the present disclosure is an apparatus forsecuring an intra-osseous device, comprising a body extending from afirst end to a second end; a cavity defined by an inner surface of thebody, and the cavity extending between a first aperture at the first endof the body and a second aperture at the second end of the body; a lockfeature positioned on the inner surface of the body, wherein the lockfeature is positioned a first predetermined distance from the first endof the body; and a channel extending from the first end to a distalpoint that is a second predetermined distance from the first end,wherein the second predetermined distance is larger than the firstpredetermined distance.

In some embodiments, the lock feature comprises a ramp portion orientedtowards the first end of the body and comprises a shoulder portionoriented towards the second end of the body, wherein the shoulderportion extends from the inner surface of the body at a substantiallyperpendicular angle. In various embodiments, the ramp portion extendsfrom the inner surface of the body at an angle between approximately 30and 60 degrees. In some embodiments, the lock feature extendscontinuously along the inner surface of the body between the channel andan additional channel.

In various embodiments, the lock feature is part of a plurality ofdiscrete lock features positioned on the inner surface of the body. Insome embodiments, the apparatus further comprises a relief aperturepositioned at the distal point of the channel, wherein the reliefaperture has an outermost width that is larger than a width of thechannel. In various embodiments, the channel extends in a direction thatis substantially parallel to a longitudinal axis of the body. In someembodiments, a cross-sectional profile of the lock feature has asemi-circular shape.

Another particular embodiments of the present disclosure is a system forsecuring an intra-osseous device, comprising a body extending from afirst end to a second end; a cavity defined by an inner surface of thebody, and the cavity extending between a first aperture at the first endof the body and a second aperture at the second end of the body; a lockfeature positioned on the inner surface of the body, wherein the lockfeature is positioned a predetermined distance from the first end of thebody, and the lock feature defines an inner diameter; and anintra-osseous device having a base portion and a needle, wherein thebase portion has an outermost diameter that is larger than the innerdiameter defined by the lock feature, and wherein the intra-osseousdevice is configured to pass the lock feature such that theintra-osseous device is secured within the body and the needle iscontained with the cavity.

In various embodiments, wherein the second aperture has an innerdiameter that is smaller than the outermost diameter of the base portionsuch that the intra-osseous device is retained within the body betweenthe second aperture and the lock feature after the intra-osseous devicepasses the lock feature. In some embodiments, the system furthercomprises a syringe selectively connected to the intra-osseous device,the syringe having a barrel with an outer diameter that is smaller thanan inner diameter of the second aperture. In various embodiments, theinner diameter of the second aperture is between 1.1-1.2 times largerthan the outer diameter of the barrel. In some embodiments, an overalllength of the intra-osseous device is smaller than an overall length ofthe body. In various embodiments, a channel extends from the first endto a distal point that is a second predetermined distance from the firstend, wherein the second predetermined distance is larger than thepredetermined distance of the lock feature.

Yet another particular embodiment of the present disclosure is a methodfor securing an intra-osseous device in a safety device, comprisingproviding an intra-osseous device with an outermost diameter; providinga safety device having a body positioned about the intra-osseous device,wherein the body has an inner surface that defines a cavity extendingbetween a first aperture at a first end of the body and a secondaperture at a second end of the body, and wherein an inner diameter ofthe second aperture is smaller than the outermost diameter of theintra-osseous device; providing a lock feature on the inner surface ofthe body, wherein the lock feature defines an inner diameter that issmaller than the outermost diameter of the intra-osseous device; drawingthe intra-osseous device through the body of the safety device towardsthe second end; and deflecting the lock feature with the intra-osseousdevice such that the intra-osseous device passes the lock feature and iscontained with the cavity.

In some embodiments, the intra-osseous device has an overall length,wherein the overall length of the intra-osseous device is smaller thanan overall length of the body of the safety device. In variousembodiments, the method further comprises selectively connecting asyringe to the intra-osseous device, wherein the syringe has a barrelwith an outer diameter that is less than the inner diameter of thesecond aperture; and removing the syringe from the intra-osseous deviceafter the intra-osseous device is secured between the lock feature andthe second aperture. In some embodiments, the method further comprisesfastening the intra-osseous device to an osseous area. In variousembodiments, the method further comprises providing a channel in thebody of the safety device that extends from the first end to a distalpoint, wherein the channel allows the lock feature to deflect and permitthe intra-osseous device to pass the lock feature. In some embodiments,the lock is positioned a first predetermined distance from the first endof the body, and the distal point of the channel is a secondpredetermined distance from the first end of the body, wherein thesecond predetermined distance is larger than the first predetermineddistance.

The Summary of the Invention is neither intended nor should it beconstrued as being representative of the full extent and scope of thepresent disclosure. The present disclosure is set forth in variouslevels of detail in the Summary of the Invention as well as in theattached drawings and the Detailed Description of the Invention and nolimitation as to the scope of the present disclosure is intended byeither the inclusion or non-inclusion of elements or components.Additional aspects of the present disclosure will become more readilyapparent from the Detailed Description, particularly when taken togetherwith the drawings.

The above-described embodiments, objectives, and configurations areneither complete nor exhaustive. As will be appreciated, otherembodiments of the disclosure are possible using, alone or incombination, one or more of the features set forth above or described indetail below.

The phrases “at least one,” “one or more,” and “and/or,” as used herein,are open-ended expressions that are both conjunctive and disjunctive inoperation. For example, each of the expressions “at least one of A, B,and C,” “at least one of A, B, or C,” “one or more of A, B, and C,” “oneor more of A, B, or C,” and “A, B, and/or C” means A alone, B alone, Calone, A and B together, A and C together, B and C together, or A, B,and C together.

Unless otherwise indicated, all numbers expressing quantities,dimensions, conditions, and so forth used in the specification andclaims are to be understood as being modified in all instances by theterm “about.”

The term “a” or “an” entity, as used herein, refers to one or more ofthat entity. As such, the terms “a” (or “an”), “one or more,” and “atleast one” can be used interchangeably herein.

The use of “including,” “comprising,” or “having” and variations thereofherein is meant to encompass the items listed thereafter and equivalentsthereof as well as additional items. Accordingly, the terms “including,”“comprising,” or “having” and variations thereof can be usedinterchangeably herein.

It shall be understood that the term “means” as used herein shall begiven its broadest possible interpretation in accordance with 35 U.S.C.§ 112(f). Accordingly, a claim incorporating the term “means” shallcover all structures, materials, or acts set forth herein, and all ofthe equivalents thereof. Further, the structures, materials, or acts andthe equivalents thereof shall include all those described in the summaryof the invention, brief description of the drawings, detaileddescription, abstract, and claims themselves.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of the specification, illustrate embodiments of the disclosure andtogether with the Summary of the Invention given above and the DetailedDescription of the drawings given below, serve to explain the principlesof these embodiments. In certain instances, details that are notnecessary for an understanding of the disclosure or that render otherdetails difficult to perceive may have been omitted. It should beunderstood, of course, that the disclosure is not necessarily limited tothe particular embodiments illustrated herein. Additionally, it shouldbe understood that the drawings are not necessarily to scale.

FIG. 1A depicts a perspective view of a safety device for removing andsecuring an intra-osseous device in accordance with an embodiment of thepresent disclosure;

FIG. 1B is a cross-sectional view of the safety device of FIG. 1A takenalong line B-B in accordance with an embodiment of the presentdisclosure;

FIG. 2 is a further perspective view of another safety device forremoving and securing an intra-osseous device in accordance with anembodiment of the present disclosure;

FIG. 3A is a perspective view of a safety device positioned about anintra-osseous device in accordance with an embodiment of the presentdisclosure;

FIG. 3B is a perspective view of a safety device guiding anintra-osseous device during removal in accordance with an embodiment ofthe present disclosure;

FIG. 3C is a perspective view of a safety device securing anintra-osseous device during removal in accordance with an embodiment ofthe present disclosure;

FIG. 4A is a perspective view of another safety device for removing andsecuring an intra-osseous device in accordance with an embodiment of thepresent disclosure;

FIG. 4B is a cross-sectional view of the safety device of FIG. 4A takenalong line B-B in accordance with an embodiment of the presentdisclosure;

FIG. 4C is another cross-sectional view of the safety device of FIG. 4Ataken along line C-C in accordance with an embodiment of the presentdisclosure;

FIG. 5A is a perspective view of another safety device for removing andsecuring an intra-osseous device in accordance with an embodiment of thepresent disclosure;

FIG. 5B is a cross-sectional view of the safety device of FIG. 5A takenalong line B-B in accordance with an embodiment of the presentdisclosure; and

FIG. 5C is another cross-sectional view of the safety device of FIG. 5Ataken along line C-C in accordance with an embodiment of the presentdisclosure.

Similar components and/or features may have the same reference label.Further, various components of the same type may be distinguished byfollowing the reference label by a letter that distinguishes among thesimilar components. If only the first reference label is used, thedescription is applicable to any one of the similar components havingthe same first reference label irrespective of the second referencelabel.

DETAILED DESCRIPTION

The present disclosure has significant benefits across a broad spectrumof endeavors. It is the Applicant's intent that this specification andthe claims appended hereto be accorded a breadth in keeping with thescope and spirit of the disclosure being disclosed despite what mightappear to be limiting language imposed by the requirements of referringto the specific examples disclosed. To acquaint persons skilled in thepertinent arts most closely related to the present disclosure, apreferred embodiment that illustrates the best mode now contemplated forputting the disclosure into practice is described herein by, and withreference to, the annexed drawings that form a part of thespecification. The exemplary embodiment is described in detail withoutattempting to describe all of the various forms and modifications inwhich the disclosure might be embodied. As such, the embodimentsdescribed herein are illustrative, and as will become apparent to thoseskilled in the arts, may be modified in numerous ways within the scopeand spirit of the disclosure.

Although the following text sets forth a detailed description ofnumerous different embodiments, it should be understood that thedetailed description is to be construed as exemplary only and does notdescribe every possible embodiment since describing every possibleembodiment would be impractical, if not impossible. Numerous alternativeembodiments could be implemented, using either current technology ortechnology developed after the filing date of this patent, which wouldstill fall within the scope of the claims. To the extent that any termrecited in the claims at the end of this patent is referred to in thispatent in a manner consistent with a single meaning, that is done forsake of clarity only so as to not confuse the reader, and it is notintended that such claim term by limited, by implication or otherwise,to that single meaning.

Various embodiments of the present disclosure are described herein andas depicted in the drawings. It is expressly understood that althoughthe figures depict safety devices, intra-osseous device, etc., thepresent disclosure is not limited to these embodiments With reference toFIGS. 1A-B, a safety device 100 that includes an enclosure body 104 inaccordance with embodiments of the present disclosure is depicted in aperspective view (FIG. 1A) and a cross-sectional view (FIG. 1B) takenalong line B-B in FIG. 1A. The enclosure body 104 in this exemplaryembodiment is in the form of a cylinder but could be other forms such asa frustum shape. A cavity 108 extends from a first aperture 112 in abottom or first end 116 of the enclosure body 104 to a second aperture124 in a top or second end 128 of the enclosure body 104. The firstaperture 112 can have a diameter that is larger than the second aperture124 to accommodate an intra-osseous device as described in furtherdetail below. The cavity 108 defines a chamber with a substantiallycylindrical volume, except for a retaining structure or lock feature 136formed between the first 112 and second 124 apertures.

The lock feature 136 can be in the form of a wedge with a ramp portion140 facing the first aperture 112 and a shoulder portion 144 facing thesecond aperture 124. The lock feature 136 can be formed continuouslyaround the inner surface of the body 104, or can be formed as discreteramp members, with gaps therebetween. In accordance with at least someembodiments of the present disclosure, the enclosure body 104 caninclude one or more channels 152 that extend from the first end 116 ofthe body 104 to a point between the lock feature 136 and the second end128 of the body 104. The channels 152 can increase the flexibility ofthe body 104, and in particular can facilitate passing a base portion ofan intra-osseous device past the lock feature 136 when withdrawing anintra-osseous device from a body, as discussed elsewhere herein. Inaccordance with at least some embodiments of the present disclosure, anend of each of the channels 152 opposite the first end 116 of the body104 can have a stress relieving aperture or feature 156.

Also shown in FIG. 1B are an inner diameter 120 of the first aperture,an inner diameter 132 of the second aperture 124, and an inner diameter148 defined by the lock feature 136. As described below these diameters120, 132, 148 function with an outermost diameter of an intra-osseousdevice such that the outermost diameter can freely pass through theinner diameter 120 of the first aperture, pass through the innerdiameter 148 of the lock feature 136 with force, and then be retainedbetween the inner diameter 148 of the lock feature 136 and the innerdiameter 132 of the second aperture 124.

With reference to FIG. 2 , a safety device 100 that includes anenclosure body 104 in accordance with other embodiments of the presentdisclosure is depicted in a transparent perspective view. The enclosurebody 104 in this exemplary embodiment is in the form of a cylinder.Similar to other embodiments of a safety device 100 in accordance withembodiments of the present disclosure, a cavity 108 extends from a firstaperture in a bottom or first end of the enclosure body 104 to a secondaperture in a top or second end of the enclosure body 104. Also similarto other embodiments of the present disclosure, the cavity 108 caninclude a containment or primary chamber that defines a substantiallycylindrical volume that extends from the first aperture to the secondaperture, except for a retaining structure or lock feature 136 formedbetween the first and second apertures.

With reference now to FIGS. 3A-C, a safety device 100 in accordance withembodiments of the present disclosure is shown being used to safelyguide and secure an intra-osseous device 304 in a body 104 of a safetydevice. As can be appreciated by one of skill in the art, theintra-osseous device 304 is typically placed in the patient body 308,and more particularly within an interior portion of a bone, using adrill (not shown) to rotate the intra-osseous device 304. The drill isthen disengaged from the intra-osseous device 304. An IV or syringe 324can then be connected to an attachment mechanism 320, such as a Luerlock, provided by a base portion 316 of the intra-osseous device 304, toenable fluids, such as medications, to be introduced to the patient body308.

As can be appreciated by one of skill in the art, removing theintra-osseous device 304 from the body is preferably done by pulling theintra-osseous device 304 from the patient body 308 along a line that iscoincident with the line along which the intra-osseous device 304 wasinstalled. In addition, the tip of the intra-osseous device 304 isusually extremely sharp, and presents a stick hazard to personnelremoving the intra-osseous device 304. A safety device 100 in accordancewith embodiments of the present disclosure provides a stabilizingstructure for removing the intra-osseous device 304, and furtherprovides containment for the intra-osseous device 304, to avoid contactbetween the intra-osseous device 304 and users of the safety device 100.

In accordance with embodiments of the present disclosure, a process forremoving the intra-osseous device 304 includes placing the firstaperture 112 of the enclosure body 104 of the safety device 100 over thebase portion 316 of the intra-osseous device 304. A syringe 324 or otherremoval tool can then be joined to the attachment mechanism 320. Inorder to facilitate applying a removing force that is coincident ornearly coincident with the line along which the device 304 is installed,the diameter of the first aperture 112 and the primary chamber can bedimensioned so that they are slightly (e.g. 0.5-2 mm) larger than thediameter of the base portion 316 of the intra-osseous device 304. Inaddition, the second aperture 124 can be dimensioned so that it has adiameter that is slightly (e.g. 0.5-2 mm) larger than a diameter of thesyringe 324 barrel 328. The second aperture 124 can also extend along aline that is coincident with a central axis of the enclosure body 104for some distance (e.g. 5-15 mm) to assist in stabilizing the syringe324. A physician or other practitioner can then hold the enclosure body104 against the patient body 308 with one hand, while pulling thesyringe 324 barrel 328 away from the patient body 308. As or after thetip of the intra-osseous device 304 is completely withdrawn from thebody, the base portion 316 of the intra-osseous device 304 is pulledpast the lock feature 136. In accordance with embodiments of the presentdisclosure, pulling the base portion 316 of the intra-osseous device 304past the lock feature 136 requires some force, and at least temporarilydeforms at least one of the lock feature 136 or the base portion 316.The intra-osseous device 304 is then retained by the lock feature 136,and contained entirely within the interior chamber, for example asdepicted in FIG. 3C.

With reference to FIGS. 4A-4C and FIGS. 5A-5C, the safety device 100 mayhave a frustum shape. The lock feature 136 can be in the form of a wedgewith a ramp portion facing the first aperture 112 a shoulder portionfacing the second aperture 124. In accordance with some embodiments ofthe present disclosure, for example as depicted in FIGS. 4B and 4C, thelock feature 136 can be provided as one or more discrete ramp members orwedges, spaced around the inner diameter of the containment chamber.Although four discrete ramp members are show in FIGS. 4B and 4C, anynumber of ramp members can be included. Moreover, the portion of theinner surface of the body 104 occupied by the ramp members can bevaried. Where the lock feature 136 is provided as more than one discreteramp member, the different ramp members can be positioned at the samedistance from the first aperture. In accordance with other someembodiments of the present disclosure, for example as depicted in FIGS.5B 5C, the lock feature 136 can extend around the inner diameter of thecontainment chamber to form a continuous ring. In accordance with stillother embodiments of the present disclosure, the lock feature 136 caninclude a spring or other elastic member, alone or in combination with amoveable tab. In at least some embodiments, the lock feature 136 isformed as an integral part of the enclosure body 104. In accordance withat least some embodiments of the present disclosure, the enclosure body104 is formed from single, integral piece of material. The material usedto form the body 104 can be, for example, a nylon, plastic,polycarbonate, or other material.

The description of the present disclosure has been presented forpurposes of illustration and description, but is not intended to beexhaustive or limiting of the disclosure to the form disclosed. Manymodifications and variations will be apparent to those of ordinary skillin the art. The embodiments described and shown in the figures werechosen and described in order to best explain the principles of thedisclosure, the practical application, and to enable those of ordinaryskill in the art to understand the disclosure.

While various embodiments of the present disclosure have been describedin detail, it is apparent that modifications and alterations of thoseembodiments will occur to those skilled in the art. Moreover, referencesmade herein to “the invention” or aspects thereof should be understoodto mean certain embodiments of the present disclosure and should notnecessarily be construed as limiting all embodiments to a particulardescription. It is to be expressly understood that such modificationsand alterations are within the scope and spirit of the presentdisclosure, as set forth in the following claims.

What is claimed is:
 1. A safety device for an intraosseous device, thesafety device comprising: a guide body having an external diameter, afirst end having a first opening, a second end having a second opening,and an internal cavity; the internal cavity connecting the first openingand the second opening; the internal cavity having a first portion witha first internal diameter and a second portion with a second internaldiameter; the first internal diameter of the first portion being lessthan the second internal diameter of the second portion; the externaldiameter of the first end being less than the external diameter of thesecond end; and a surface of the second end being planar; and portion,wherein the at least one protrusion has an internal diameter that isapproximately the same as an external diameter of a barrel of a syringeengaged to a base of the intraosseous device.
 2. The safety device ofclaim 1, wherein the first internal diameter of the first portion isslightly larger than the intraosseous device.
 3. The safety device ofclaim 2, wherein the second internal diameter of the second portion islarger than a barrel of a syringe or a removal tool configured to engagethe intraosseous device.
 4. The safety device of claim 1, furthercomprising an exterior surface, the exterior surface being tapered fromthe second end to the first end such that the exterior surface has afrustum shape between the first end and the second end of the guidebody.
 5. The safety device of claim 1, wherein the at least oneprotrusion extends from a sidewall of the internal cavity, and whereinthe at least one protrusion has a smaller internal diameter than thefirst portion of the internal cavity.
 6. The safety device of claim 1,wherein the second portion has a length that is longer than theintraosseous device.
 7. The safety device of claim 1, wherein the atleast one protrusion is a locking feature located between the firstportion and the second portion.
 8. The safety device of claim 7, whereinthe locking feature is configured to engage a feature of theintraosseous device.
 9. The safety device of claim 1, wherein the firstportion, the second portion, and the at least one protrusion areconcentric.
 10. The safety device of claim 1, wherein the at least oneprotrusion has an internal diameter that is approximately the same as anexternal diameter of a barrel of a syringe.
 11. A safety guide for anintraosseous device, the safety guide comprising: a guide body having afirst end having a first aperture and a second end having a secondaperture, an internal surface defining a cavity connecting the firstaperture to the second aperture, wherein the first aperture, the secondaperture, and the cavity are concentric, wherein the second end has asurface that is substantially planar, wherein a diameter of the firstaperture is smaller than a diameter of the second aperture; and a firstchamber beginning at the first aperture and a second chamber beginningat the second aperture, wherein the first chamber and the second chamberare separated by a locking feature, wherein the locking featurecontinuously extends around an inner circumference of the internalsurface, wherein the locking feature is concentric with the firstaperture and the second aperture, and wherein the locking feature has aninternal diameter that is approximately the same as an external diameterof a barrel of a syringe engaged to a base of the intraosseous device.12. The safety guide of claim 11, wherein the locking feature is atleast one protrusion extending from the internal surface, wherein theprotrusion is concentric with the first aperture and the secondaperture.
 13. The safety guide of claim 11, wherein the locking featureis configured to engage the intraosseous device.
 14. The safety guide ofclaim 11, wherein an internal diameter of the first chamber is slightlylarger than the intraosseous device.
 15. The safety guide of claim 14,wherein an internal diameter of the second chamber is larger than abarrel of a syringe or a removal tool configured to engage theintraosseous device.
 16. The safety guide of claim 11, furthercomprising a channel extending from the second end into at least aportion of the first chamber.
 17. The safety guide of claim 11, whereinan internal diameter of the second chamber increases from the lockingfeature to the second end.
 18. The safety guide of claim 11, wherein thelocking feature is located a specific distance from the second end. 19.The safety guide of claim 11, wherein an external width of the guidebody increases from the first end to the second end.
 20. An intraosseousdevice, the intraosseous device comprising: a syringe having a barreland a plunger; said barrel having an external diameter; a guard bodyhaving a first end having a first aperture, a second end having a secondaperture, a cavity defined by an internal surface of the guard body, anda locking feature; an internal diameter of the first aperture and aninternal diameter of the second aperture are each larger than theexternal diameter of the barrel; the guard body having an exteriorsurface and an exterior width, the exterior width increasing from thefirst end to the second end; the cavity having a first chamber and asecond chamber separated by the locking feature; the first chamberhaving at least one protrusion into the cavity, the at least oneprotrusion being concentric with the first aperture and the secondaperture and the at least one protrusion having an internal diameterthat is approximately the same as the external diameter of the barrel;the second chamber having an internal diameter that increases from thelocking feature to the second end; the second end being planar; and atleast one channel along the exterior surface.